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CTRI Number  CTRI/2024/12/077793 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 27/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   How metoclopramide affects stomach contents in diabetes mellitus patients before surgery for elective procedures 
Scientific Title of Study   Effect of metoclopramide on gastric residual volume as measured by ultrasonography in diabetes mellitus patients undergoing elective surgeries: A randomized controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hari Haran N 
Designation  First year junior resident 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Department of Anaesthesiology, AIIMS Bathinda, PUNJAB

Bathinda
PUNJAB
151001
India 
Phone  09655601229  
Fax    
Email  hariharankrr489@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mayank Gupta 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Department of Anaesthesiology, AIIMS Bathinda, PUNJAB

Bathinda
PUNJAB
151001
India 
Phone  09655601229  
Fax    
Email  mayankgupta6682@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hari Haran N 
Designation  First year junior resident 
Affiliation  All India Institute of Medical Sciences, Bathinda 
Address  Department of Anaesthesiology, AIIMS Bathinda, PUNJAB

Bathinda
PUNJAB
151001
India 
Phone  09655601229  
Fax    
Email  hariharankrr489@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Bathinda, Punjab,India,151001 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Bathinda 
Address  Bathinda Punjab India 151001 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hari Haran N  All India Institute of Medical Sciences, Bathinda  Department of Anaesthesiology
Bathinda
PUNJAB 
09655601229

hariharankrr489@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  group A- diabetes mellitus patients will receive metoclopramide  Diabetes mellitus patients posted for elective surgeries will be kept nil per oral for 8 hrs. Baseline HbA1c , fasting blood sugar , duration of diabetes mellitus , type of treatment received will be assessed. ASA standard monitors will be attached and widebore intravenous cannula secured. Gastric ultrasonography will be done before administering metoclopramide 10mg (2ml) and second time done 30 mins after giving metoclopramide. Based on gastric residual volume calculated through gastric ultrasound, risk of aspiration can be measured and informed to anaesthesiologist for anaesthesia and airway plan. Just before extubation third time gastric residual volume will be calculated through gastric ultrasound. After surgery , in post operative period nausea , vomiting, regurgitation and aspiration will be asked at 6 hrs, 12 hrs and 24 hrs. 
Intervention  group B- diabetes mellitus patients will receive placebo (normal saline)  Diabetes mellitus patients posted for elective surgeries will be kept nil per oral for 8 hrs. Baseline HbA1c , fasting blood sugar , duration of diabetes mellitus , type of treatment received will be assessed. ASA standard monitors will be attached and widebore intravenous cannula secured. Gastric ultrasonography will be done before administering normal saline (2ml) and second time done 30 mins after giving normal saline. Based on gastric residual volume calculated through gastric ultrasound, risk of aspiration can be measured and informed to anaesthesiologist for anaesthesia and airway plan. Just before extubation third time again gastric residual volume will be calculated through gastric ultrasound. After surgery , in post operative period nausea , vomiting, regurgitation and aspiration will be asked at 6 hrs, 12 hrs and 24 hrs. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients between 18 and 65 years of age of either gender.
ASA-PS 2 or 3 patients with diabetes mellitus scheduled for elective surgeries under general anaesthesia. 
 
ExclusionCriteria 
Details  Patients who are not willing to give consent.
patients with partial and total gastrectomies.
Patients undergoing gastro-intestinal surgeries.
patients who are allergic to study drug(metoclopramide)
patients who have increased intracranial pressure.
patients who are unable to lie in the right lateral decubitus position.
Factors responsible for gastroparesis other than diabetes mellitus (like pregnancy, hypothyroidism, multiple sclerosis)
Those who are on medications like opioids, anti-depressants, anti-cholinergics 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of metoclopramide on gastric residual volume as measured by ultrasonography in diabetes mellitus patients undergoing elective surgeries  gastric residual volume measured before and 30 mins after administering drug or normal saline and just before extubation also. 
 
Secondary Outcome  
Outcome  TimePoints 
To grade the aspiration risk by measuring gastric residual volume in diabetes mellitus patients.
To compare post operative nausea , vomiting, regurgitation and aspiration among two groups.
To assess whether any change in anaesthesia and airway plan based on gastric residual volume. 
post operative nausea, vomiting, regurgitation and aspiration assessed at 6 hrs,12 hrs and 24 hrs. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   09/12/2024 
Date of Study Completion (India) 16/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This study is about to compare the effect of metoclopramide on gastric residual volume as measured by ultrasonography in DM patients undergoing elective surgeries. All patients will be kept nil per oral for at least 8 hours before surgery. Baseline HbA1C, fasting blood sugar, duration of DM, treatment for DM, ASA-PS grade and duration of fasting in hours will be noted on arrival at the preoperative area. A wide bore intravenous line will be secured. ASA standard monitors will be attached, as well as baseline parameters will be recorded. After getting informed written consent, gastric ultrasonography will be done in right lateral decubitus position to assess the gastric residual volume -1 (GRV-1) by measuring the gastric antral cross-sectional area before administering metoclopramide or placebo.

After that, metoclopramide 10 mg (2ml) intravenous will be given to one set of patients with DM (group A), and 2 ml NS (placebo) will be given to another set of patients with DM (group B). After 30 minutes, gastric ultrasonography will be done again in right lateral decubitus position to measure the gastric antral CSA. From the CSA of the gastric antrum, we will calculate GRV-2 by the following formula described by Perlas et al.

[GRV: 27+ (14.6×RIGHT LATERAL CSA)-(1.28×AGE)}

a) Low risk: patients who have a GRV of less than 1.5mL/kg.

(b) High risk: patients who have a GRV of more than 1.5mL/kg. 

Before conveying GRV findings, the anaesthesiologists responsible for intraoperative management but blinded to the group allocation will be asked about the anaesthesia and airway plan. Then these GRV values will conveyed to the anaesthesiologists. Based on these GRV values, the anaesthesiologists will decide the anaesthesia plan and airway plan (GETA or SGA). Gastric ultrasonography will again be done at the end of surgery before extubation to measure GRV-3. In patients whom the surgery has been completed will assess the post operative nausea, vomiting, regurgitation and aspiration at 6 hrs, 12 hrs and at 24 hrs.

Endpoint: Post operative nausea, vomiting, regurgitation and aspiration assessment for twenty-four hours after the completion of surgery.

Primary objective: To evaluate the effect of metoclopramide on GRV as measured by ultrasonography in DM patients undergoing elective surgeries.

Secondary objectives:

(1) To grade the aspiration risk by measuring GRV in DM patients undergoing elective surgeries.

(2) To compare post operative nausea, vomiting, regurgitation and aspiration among the two groups.

(3) To assess whether there is any change in the anaesthesia and airway plan based upon gastric ultrasonography findings

 
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